Prescription drug · NDA
Miplyffa (Arimoclomol citrate) NDC 72542-124
Arimoclomol citrate 124 mg/1 · Capsule · Oral · Acer Therapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72542-124-01 | 72542012401 | 1 BOTTLE in 1 CARTON (72542-124-01) / 90 CAPSULE in 1 BOTTLEMarketed from Sep 20, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Miplyffa
- Generic name (nonproprietary)
- arimoclomol citrate
- Active ingredients
- Arimoclomol citrate — 124 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Acer Therapeutics Inc.NDC labeler code 72542
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214927
- Marketing start
- Listing expires
- Other FDA classes
- Organic Cation Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 72542-124_18850625-1a1d-4351-862e-5d46b08eb978SPL ID 18850625-1a1d-4351-862e-5d46b08eb978SPL set ID 5feffc0e-453d-47fa-91dd-38d4952309bcRxCUI 2694288, 2694294, 2694296, 2694298, 2694300, 2694302, 2694304, 2694306UNII Q85FFY6179UPC 0372542147018
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472542012401followed by a unit qualifier and the quantityPackage 72542-0124-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 72542-124
- What is NDC 72542-124?
- 72542-124 is the product NDC for Miplyffa (arimoclomol citrate), Arimoclomol citrate 124 mg/1 capsule, listed with the FDA by Acer Therapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miplyffa (Arimoclomol citrate).
- What is the active ingredient?
- Arimoclomol citrate.
- Who is the labeler?
- Acer Therapeutics Inc., NDC labeler code 72542. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Miplyffa?
- 3 other product NDCs are listed under this name. See all Miplyffa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miplyffa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Miplyffaarimoclomol citrate | Arimoclomol citrate 47 mg/1 | CapsuleOral | Acer Therapeutics Inc. | 72542-147 | 72542-0147-01 |
| Miplyffaarimoclomol citrate | Arimoclomol citrate 62 mg/1 | CapsuleOral | Acer Therapeutics Inc. | 72542-162 | 72542-0162-01 |
| Miplyffaarimoclomol citrate | Arimoclomol citrate 93 mg/1 | CapsuleOral | Acer Therapeutics Inc. | 72542-193 | 72542-0193-01 |
Other NDCs under NDA 214927
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Miplyffaarimoclomol citrate | Arimoclomol citrate 47 mg/1 | CapsuleOral | Acer Therapeutics Inc. | 72542-147 |
| Miplyffaarimoclomol citrate | Arimoclomol citrate 62 mg/1 | CapsuleOral | Acer Therapeutics Inc. | 72542-162 |
| Miplyffaarimoclomol citrate | Arimoclomol citrate 93 mg/1 | CapsuleOral | Acer Therapeutics Inc. | 72542-193 |